Defibrillator regulations in Extremadura

DECREE 16/2019, of March 12, which regulates the installation of automated external defibrillators (AEDs) in the non-health field, the authorization for their use and the training associated with it.

The Constitution, in its article 43, recognizes the right to health protection and declares that it is the responsibility of the public powers to organize and protect public health, through preventive measures and the necessary benefits and services.

Law 14/1986, of April 25, General Health, has as its purpose the general regulation of all actions that allow the right to health protection to be made effective, and establishes in its article 6.4 that the actions of the Administrations Public Health Services will be aimed at guaranteeing, among other things, health care in all cases of loss of health.

For its part, Law 16/2003, of May 28, on the cohesion and quality of the National Health System, includes in its article 2 the provision of comprehensive health care, comprehensive of both its promotion and the prevention of diseases. , assistance and rehabilitation, detailing in its article 11 the public health benefits.

The Statute of Autonomy of Extremadura attributes, in article 9.1.24, to the Autonomous Community of Extremadura, the exclusive competence in health and public health in relation to the organization, internal operation, coordination and control of the centers, services and establishments health, participation in the planning and general coordination of health, as well as in the promotion of health and biomedical research.

In this sense, Law 10/2001, of June 28, on Health of Extremadura, provides in its article 6 that the Public Administrations of the Autonomous Community, within the scope of their powers, will guarantee the right to health protection. and the health care of citizens, and will establish limitations and preventive measures in relation to public and private activities that may have negative consequences for health.

Likewise, Law 7/2011, of March 23, on public health of Extremadura, establishes in its article 8.c, as attributions of the Public Administrations, to adopt as many measures as are necessary to avoid risks to health and preserve it. ; and in its article 28.1 it understands by prevention of diseases, health problems and deficiencies, the set of actions and services aimed at reducing and, where appropriate, eliminating the appearance of certain diseases in the population and attenuating their consequences through, among other individual and collective actions, early treatment.

Cardiovascular diseases constitute an important problem in the field of public health, since they constitute the main cause of death worldwide, nationally and in the Autonomous Community of Extremadura. Among all health emergency situations, cardiorespiratory arrest is seen as a unique situation in which the objective is to recover life, avoiding or minimizing the sequelae. The most frequent causes of this situation in adults in the out-of-hospital environment are ventricular fibrillation and pulseless ventricular tachycardia, and it is scientifically recognized that early electrical defibrillation is the most effective way to prevent deaths for this reason.

Proper attention to cardiorespiratory arrest requires that the first person to arrive on the scene (first responder) carry out a rapid application of the actions contemplated in the chain of survival, made up of four interrelated links: recognition of the situation and immediate alert to the emergency services before a possible stop; early initiation of basic cardiopulmonary resuscitation (CPR); early defibrillation; and advanced life support in a few minutes.

Early electrical defibrillation is an effective treatment against ventricular fibrillation, so the action of the first responder is essential. The automated, automatic and semiautomatic external defibrillator, due to its operating and safety characteristics, enables people with minimal education and training to perform defibrillation actions. Because their use does not require a prior clinical diagnosis, these defibrillators are suitable for use by people outside the healthcare profession.

Royal Decree 365/2009, of March 20, basic state regulations under the provisions of article 149.1.16.a of the Constitution, establishes the minimum conditions and requirements for safety and quality in the use of automatic and semi-automatic defibrillators outside the health field, and grants the Autonomous Communities the responsibility of establishing the appropriate control and inspection mechanisms, as well as promoting their installation and coordination with other devices.

In Extremadura, prior to the approval of Royal Decree 365/2009, of March 20, which establishes the conditions and minimum safety and quality requirements for the use of automatic and semi-automatic external defibrillators outside the health field, the use of external semiautomatic defibrillators by non-medical personnel was regulated in Decree 10/2008, of January 25, which regulates the use of external semiautomatic defibrillators by non-medical personnel and in the Order of October 23, 2009, by which The minimum requirements for accreditation of entities and training activities for the use of external semiautomatic defibrillators by non-medical personnel are established.

The accumulated experience since the approval of Decree 10/2008, of January 25, the innovations introduced in the basic state regulations, the scientific evidence available in this regard, the high degree of awareness of society regarding the problem of sudden cardiac death, and the interest of the Health Administration of the Junta de Extremadura in promoting and facilitating the use of defibrillators in the non-health field, given the possibility of improving survival expectations thanks to citizen solidarity, make the approval of a new regulation advisable.

The new regulation introduces: the obligation to have these defibrillators in certain spaces where there is a high concurrence of people and there is a probability of a cardiac arrest occurring, the need for authorization for the use of these defibrillators and the entities that provide the training, as well as the creation of the "Registry of DEA Extremadura in the non-health field" and the "Registry of training for the use of DEA in Extremadura", which will integrate those created by the aforementioned Decree 10/2008, optimizing their utilities and being accessible to the Emergency and Health Emergencies System of Extremadura and to the 112 Emergency Care Center of Extremadura.

The draft decree has maintained the requirement of authorization to acquire the status of provider of training activities, thus assuming an approach that underlies the desire to maximize guarantees in relation to the installation of this type of device above any another consideration, so that the projected regulation is justified in the relevance of the interests at stake, which are none other than the protection of the health of the potential recipients of the defibrillators.

In this provision, the principle of equal treatment between women and men has been taken into account, in accordance with the provisions of the Constitution, in Organic Law 3/2007, of March 22, for the effective equality of women and men. , and in Law 8/2011, of March 23, on Equality between women and men and against gender violence in Extremadura, making use of inclusive language in order to contribute to the achievement of equality between women and men. .

By virtue of the foregoing, and in accordance with the provisions of article 90.2 of Law 1/2002, of February 28, of the Government and Administration of the Autonomous Community of Extremadura, after hearing the Legal Commission of Extremadura, at the proposal of the Minister of Health and Social Policies and after deliberation by the Governing Council at its meeting on March 12, 2019,

 

I HAVE

 

CHAPTER I

General disposition

 

Article 1

Purpose and Scope

 

The purpose of this decree is to regulate, within the scope of the Autonomous Community of Extremadura:

 

• a) The obligation of the availability of automated, automatic and semi-automatic external defibrillators (hereinafter DEA), in certain spaces where there is a high concurrence of people and there is a probability of a cardiac arrest occurring.
• b) The authorization for the use of DEA in the non-health field.
• c) The authorization of the entities that provide training activities in the use of AED in the non-health field, as well as of the instructors who provide this training.
• d) The creation of the "Registry of DEA Extremadura in the non-health field" and the "Registry of training for the use of DEA in Extremadura".

 

Article 2

Definitions

 

For the purposes of this decree, it is understood by:

1. a) Automated external defibrillator (AED): Medical device intended to analyze the heart rhythm, identify fatal arrhythmias requiring defibrillation and administer, with the intervention of a person, an electric shock in order to restore a viable heart rhythm with high levels of security. It includes two types:

• — Automatic external defibrillator: The device itself is the one that performs the entire sequence including the discharge, with which the user only has to turn it on and follow the steps indicated by the device.
• — Semiautomatic external defibrillator: Human action includes, in addition to turning it on and following the indicated steps, pressing the defibrillation button when indicated by the device.

For the purposes of this decree, the abbreviation DEA will include both automatic and semi-automatic external defibrillators, with all the provisions of the decree being applicable to them.

 b) DEA holder: Natural or legal person who is the owner or responsible for the management or exploitation of the space or place, public or private, where a DEA is installed in the non-health field.

c) First responder: Person who has initial contact with the patient and makes use of an AED in the non-health field.

d) Provider entity: Authorized physical or legal person who organizes or promotes a training activity in the use of AED in the non-health field.

e) Instructor: Person who provides training in the use of DEA in the non-health field.

f) Capacity: Maximum public occupancy granted by the corresponding municipal authority or permitted by current regulations in establishments intended for the celebration or practice of public shows or recreational activities.

g) Public establishments: Those buildings, premises or venues accessible to public attendance, in which public shows and recreational activities take place, without prejudice to the fact that said shows and activities can be carried out in portable, removable facilities or on the road. and specifically the establishments included in the list attached to the General Police Regulations for Public Shows and Recreational Activities, approved by Royal Decree 2816/1982, of August 27.

h) Educational center: Educational center where non-university and university education is taught, public or private.

i) Sports center: That sports facility that has a set of sports spaces under the same management unit in a joint location thereof.

j) Sports complex: Set of sports facilities close and related to each other, with several different access points to the different sports spaces.

k) Sports facility: Set made up of one or more sports spaces and the auxiliary service spaces essential for its operation.

l) Sports facilities with restricted accessibility: Those sports facilities attached to priority non-sports use centers and which are not accessible to the general population, but provide exclusive service to military, police and security forces centers, and prisons.

m) Collective commercial equipment: Set of commercial establishments integrated into a building or complex of buildings delimited by a single enclosure with interior areas and/or common urban elements, in which activities are carried out in an independent business manner, sharing for this purpose an image, management and/or common services.

n) Recreation Center: Conditioned space for recreational and entertainment activities.

ñ) Workplace: Space in which workers must remain or to which they must access for work reasons.

o) Responsible for the treatment: The natural or legal person, public authority, service or other body that, alone or jointly with others, determines the purposes and means of the processing of personal data.

 

CHAPTER II

Installation and use of DEA in the non-health field

 

Article 3

Spaces required to have DEA

 

The following spaces or places, public or private, are required to have an AED in suitable operating conditions and ready for immediate use:

 

• a) Commercial centers and facilities, individual or collective, with a sales area equal to or greater than 2.500 m2. If they are distributed over several floors, at least two DEAs must be installed, one on the ground floor and the other on the upper floor. In the case of collective commercial facilities, an additional DEA must be installed in each commercial establishment of the same that equals or exceeds 2.500 m2 of sales area.
• b) Transport facilities: airports and bus or railway stations, for towns with more than 30.000 inhabitants.
• c) Non-sanitary emergency services that can be first responders, such as firefighters, local police and civil protection in towns with more than 30.000 inhabitants.
• d) Sports or recreational facilities, centers or complexes in which the capacity, taking into account all its available sports spaces, is equal to or greater than 700 people. Sports facilities with restricted accessibility are excluded.
• e) Public establishments, venues and facilities in which public shows are held, with an authorized capacity equal to or greater than 1.000 people.
• f) Educational centers with a capacity equal to or greater than 500 students.
• g) Work centers with more than 250 workers.

 

Article 4

Promotion of the installation of AEDs

 

1. The Health Administrations of the Autonomous Community of Extremadura, within the scope of their powers, will promote the installation and use of AEDs in places and spaces where, even though they are not obliged to do so, their installation may be considered convenient because there is a concentration or transit in them. large number of people.
2. The installation of DEA will be promoted in the following spaces and places:

• — Commercial centers and facilities, individual or collective, with a sales area equal to or greater than 1.000 m2.
• — Land transport stations in towns with more than 15.000 inhabitants.
• — Facilities, centers, sports or recreational complexes, public or private, with a capacity equal to or greater than 400 people.
• — Public establishments, venues and facilities in which public shows are held, with authorized capacity equal to or greater than 500 people.
• — Non-health emergency services that can be first responders, such as firefighters, local police and civil protection, in towns with more than 5.000 inhabitants.
• — Residential centers with a capacity of more than 80 beds, for people with disabilities, mental disorders, cognitive impairment, the elderly or any other group that, due to their special conditions of physical vulnerability or psychosocial risk, so advises it.

 

Article 5

Obligations of the person holding the DEA

 

The obligations of the owner of the space or place where a DEA is installed, whether mandatory or voluntary, will be:

 

1. Guarantee that the installation complies with the requirements of Royal Decree 365/2009, of March 20, which establishes the minimum conditions and requirements for safety and quality in the use of automatic and semi-automatic external defibrillators outside of the health field, and in Royal Decree 1591/2009, of October 16, which regulates medical devices, bearing the CE marking that guarantees their conformity with the essential requirements that apply to them.
2. Ensure its maintenance and conservation.
3. Locate them in a visible and suitable space for their installation, and that their location is marked clearly and simply using the universal signage recommended by the International Resuscitation Coordination Committee (ILCOR) according to the model that appears in annex I, consisting of the label corresponding to the emergency telephone number 112 and the instructions for its use must be visible. Said location must be duly identified in the plans or informative maps of the place, if any.
4. Have authorized personnel for its use, in accordance with the provisions of article 7 of this standard, during the entire time that the space or place remains open to the public, except in the case of devices located on public roads. The person who owns the DEA will designate the personnel responsible for its management, with preference for those authorized persons whose location allows them easy access to it.
5. Previously provide the personnel in charge of managing the DEA with the training and updating of the knowledge necessary for its use, in accordance with the provisions of this decree.
6. Declare the installation, withdrawal or modification of AED data to the health authority.

 

Article 6

Declaration responsible for the installation, suspension, withdrawal or modification of data of an AED

 

1. The person holding the DEA will be obliged to submit a responsible declaration of the installation, suspension, withdrawal or modification of its data, prior to its taking place, before the General Directorate competent for health care of the Extremadura Health Service. (hereinafter SES).
2. The responsible declaration of installation, suspension, withdrawal or modification of data of a DEA will be made in accordance with the provisions of annex II of this decree. Once completed, it may be presented in the places contemplated in article 7.1 of Decree 257/2009, of December 18, which establishes a Single Registry System and regulates its administrative functions in the field of Administration. of the Autonomous Community of Extremadura or in any of the places established in article 16.4 of Law 39/2015, of October 1, on the Common Administrative Procedure of Public Administrations, as well as electronically, through the address electronics http://sede.juntaex.es.
3. The responsible declaration of installation, suspension, withdrawal or modification of data of a DEA will have the effect of its corresponding registration ex officio in the "Registry of DEA Extremadura in the non-health field".

 

Article 7

AED use

 

1. Any use of the DEA must be preceded by the notification and activation of the 112 Emergency Care Center of Extremadura.
2. The use of the AED in the non-health field must be carried out by persons authorized to do so:

• a) People with a degree or degree in medicine, a diploma or degree in nursing, or medium-level health emergency technicians.
• b) People of legal age who prove they have received training in accordance with the provisions of article 10 of this decree, and are registered in the "Training Registry for the use of DEA in Extremadura", section of "Persons authorized to use DEA in the non-health field”.

3. In the absence of the above, anyone can apply defibrillation for therapeutic purposes.
4. On the part of the 112 Emergency and Emergency Care Center of Extremadura, the registration of the incidents will be carried out, for their information and possible statistical use.

 

CHAPTER III

Training for the use of AED in the non-health field

 

Article 8

Authorized provider entities of training activities in the use of AED in the non-health field

 

1. To acquire the status of authorized provider of training activities in use of DEA in Extremadura, interested natural or legal persons must request authorization from the General Directorate competent for training of the Ministry responsible for health.
2. Self-employed workers and entities, both public and private, whose activities include training may submit an authorization request. In any case, they must meet the following requirements:

• a) Have a teaching team, whose instructors are registered and updated in the "Training Registry for the use of DEA in Extremadura", section "Instructors in the use of DEA in the non-health field", among which there will be personnel with a degree or degree in medicine, a university diploma or graduate in nursing, or a medium-level technician in health emergencies, to direct each of the training activities in use of DEA.
• b) To have premises that allow the imparting of training, both theoretical and practical.
• c) Have the teaching material that allows the training to be given, in accordance with the provisions of Annex V.
• d) Have a training program that meets the requirements and basic content set out in Annex V.
• e) In the case of using logos and trademarks for their training activity, they must have their ownership and registration.

3. The request will be made in accordance with the provisions of annex III of this decree. Once completed, it may be presented in the places contemplated in article 7.1 of Decree 257/2009, of December 18, which establishes a Single Registry System and regulates its administrative functions in the field of Administration. of the Autonomous Community of Extremadura or in any of the places established in article 16.4 of Law 39/2015, of October 1, on the common administrative procedure of public administrations, as well as electronically, through the address electronics http://sede.juntaex.es.
4. The request must be accompanied by:

• a) Training program to be taught in the initial training and retraining courses, adjusted to the provisions of Annex V.
• b) Tax identification card of the requesting entity, as well as the electronic code provided in the communication of the card accrediting the tax identification number. If it is a self-employed person, they will be the documents that prove it (registration in the Treasury and Social Security). Public bodies will be exempt from the requirements contained in this section.

5. If the application or documentation presented does not meet the indicated requirements, or the necessary documentation is not presented, the interested party will be required to correct the lack or provide the documents within ten business days from the date of the request. mandatory, indicating that if you do not do so, your request will be considered withdrawn, after a resolution that must be issued in the terms provided in article 68.1 of Law 39/2015, of October 1, on Administrative Procedure Common for Public Administrations.
6. Once the application is correctly and completely submitted with the required documentation, the General Directorate with competences in matters of training of the Ministry responsible for health will proceed to issue and notify the corresponding resolution within a maximum period of four months. Once said period has elapsed without an express resolution, the authorization shall be understood to have been granted. Against this resolution, which does not put an end to the administrative process, an appeal may be filed, within a period of one month, before the person in charge of the Ministry competent in matters of health, in accordance with the provisions of articles 121 and 122. of Law 39/2015, of October 1, on the Common Administrative Procedure of Public Administrations.
7. The authorization as a training provider entity for the use of DEA will be valid for three years, counted from the date of the authorization resolution. Within the three months prior to the expiration of the term of validity, interested persons may request its renewal, in accordance with the content established in annex III of this decree. Failure to request renewal within the indicated period will result in the expiration of the authorization automatically.
8. The authorization as a provider entity will have the effect of registering it in the "Registration of training for the use of DEA in Extremadura", section of "Authorized provider entities of training activities in the use of DEA in the non-health field".
9. It will be the responsibility of the provider entities that the training activities organized, both initial training and recycling, meet the requirements set out in annex V. If this is not the case, they will be considered invalid activities for the registration or renewal of students in the " Training registry for the use of DEA in Extremadura”, section of “Persons authorized to use DEA in the non-health field”.

 

Article 9

Instructors in the use of AED in the non-health field

 

1. To be able to carry out the training activities in use of DEA in Extremadura, the instructors must be registered in the "Registration of training for use of DEA in Extremadura", section of "Instructors in use of DEA in the non-healthcare field" .
2. Interested persons must apply for this registration to the General Directorate responsible for training of the Ministry responsible for health, having to meet, where appropriate, the following requirements:

• a) Have an accrediting degree as an instructor in the use of DEA (basic life support, basic life support and automatic external defibrillation, immediate life support or advanced life support) based on training activities of trainers recognized by the Spanish Council of Cardiopulmonary Resuscitation (CERCP), the European Resuscitation Council (ERC) or the American Heart Association (AHA).
• b) Have certification of having participated, during the last three years, as a speaker in a training activity in the use of DEA recognized by the CERCP, the ERC, the AHA or by a provider entity registered in Extremadura, in the event that the Instructor qualification required in the previous section has been issued more than three years ago.
• The request must be accompanied by:

1. a) Copy of the accreditation qualification as an instructor in the use of DEA, recognized by the CERCP, the ERC or the AHA in the last three years.
2. b) Only if the qualification as an instructor is more than three years old: certification of having participated during the last three years as a speaker in a training activity for the use of AEDs recognized by the CERCP, the ERC, the AHA or by a registered provider entity to provide DEA training in Extremadura.
3. c) For the purposes of being able to exercise the Directorate of training activities for the use of DEA, those interested persons who have a degree or degree in medicine, a diploma or degree in nursing, or a technician in medium-level health emergencies, must provide said Title.
4. The request will be made in accordance with the provisions of annex IV of this decree. Once completed, it may be presented in the places contemplated in article 7.1 of Decree 257/2009, of December 18, which establishes a Single Registry System and regulates its administrative functions in the field of Administration. of the Autonomous Community of Extremadura or in any of the places established in article 16.4 of Law 39/2015, of October 1, on the Common Administrative Procedure of Public Administrations, as well as electronically, through the address electronic http://sede.juntaex.es.
5. If the application or documentation presented does not meet the indicated requirements, or the necessary documentation is not presented, the interested party will be required to correct the lack or provide the documents within ten business days from the date of the request. mandatory, indicating that if you do not do so, your request will be considered withdrawn, after a resolution that must be issued in the terms provided in article 68.1 of Law 39/2015, of October 1, on Administrative Procedure Common for Public Administrations.
6. Once the application is correctly and completely submitted with the required documentation, the General Directorate with competences in matters of training of the Ministry responsible for health will proceed to make the corresponding registration in the "Training Register for DEA use in Extremadura", section of "Instructors in the use of DEA in the non-health field". This registration will expressly include its period of validity, which will be three years from the date of issuance of the accrediting degree recognized by the CERCP, the ERC or the AHA or the certification included in point 2.b) of this article. .
7. During the three months prior to its expiration, the renewal of this registration may be requested from the General Directorate with competences in training of the Ministry responsible for health, with the content established in annex IV and accompanied by certification of having participated, during the last three years, as a speaker in a training activity for AED use recognized by the CERCP, the ERC, the AHA or by a provider entity registered in Extremadura. The renewal will expressly include its period of validity, which will be three years. Failure to request renewal within the indicated period will result in the expiration of the registration automatically.

 

Article 10

Training activities for the use of AED

 

1. The training activities for the use of DEA, whose basic requirements and contents are included in annex V of this decree, can be initial training activities or recycling, and are intended to acquire the necessary knowledge and skills of basic life support. and adequate management of the AED, in order to know how to act in urgent and emergency situations in patients with cardiorespiratory arrest.
2. Training activities for the use of DEA carried out in Extremadura:

• a) The training activities will be organized and taught by the provider entities authorized in accordance with this decree.
• b) Each training activity will have a person who exercises its direction, appointed by the corresponding authorized provider entity, from among the authorized instructors who, in addition, have a degree or degree in medicine, diploma or degree in nursing, or technical /a in medium-grade health emergencies.
• c) Once the training activity is completed, the authorized provider entity must present, to the General Directorate with competences in matters of training of the Ministry responsible for health, within a maximum period of 20 working days, a report of the training activity carried out, which will include :

1. — Program of the training activity given.
2. — Final list of the instructors and the direction of the training activity.
3. — Final list of people trained for the use of the DEA, with expression of name, two surnames and DNI.

• d) The authorized provider entities must deliver the corresponding certificate accrediting the completion of the training to the people who have achieved it. The certificate must mention that the training has been given by an entity authorized by the General Directorate with training competencies of the Ministry responsible for health, in accordance with the training program established for this purpose, and include the signature of the entity's legal representative. and the person who carries out the direction of the activity.

3. Training activities for the use of DEA carried out in other Autonomous Communities:

• a) The training activities recognized by the competent authorities of other CCAAs must include the minimum content and duration established in annex V of this decree.
• b) In this case, it will be the person who owns the DEA who must send the following documentation to the General Directorate with competences in matters of training of the Ministry responsible for health:

1. — Certificate of completion of the initial training or recycling activity, carried out during the last three years, indicating that the provider entity issuing it is authorized in the corresponding Autonomous Community.
2. — Training program of the training activity, stating the duration (practical and theoretical hours), and the contents received.

Once the documentation provided has been reviewed and compliance with the necessary requirements has been verified by the General Directorate with competences in the field of training of the Ministry responsible for health, the latter will proceed to register ex officio the people trained in the "Training Register for use of DEA in Extremadura”, section of “Persons authorized to use DEA in the non-health field”. This registration will be valid for three years from the date of completion of the DEA use training activity, and may be renewed, for periods of the same duration, through a DEA use recycling training activity. Failure to pass or participate in this recycling training throughout the term of registration will result in its expiration, automatically.

 

CHAPTER IV

Records!

 

Article 11

Administrative records

 

1. In order to be able to carry out the necessary monitoring and control of the activities regulated in this decree, the following records are created in accordance with the provisions of current regulations in relation to the treatment and protection of personal data:

• a) "Registration of DEA Extremadura in the non-health field": It will be attached to the General Directorate competent in matters of health care of the SES, which will exercise the functions of person responsible for the processing of personal data. The purpose of this registry will be to provide the Health Emergencies and Emergencies System of Extremadura with a complete map of the deployment in the Autonomous Community of the AEDs that are installed in the non-health field, to improve the effectiveness and efficiency of the care response to a cardiac arrest, and know the data related to their use.

All the data contained in the responsible declarations to the health authority for the installation, suspension, withdrawal or modification of data of an AED in the non-health field will be recorded in this registry.

 

1. b) "Record of training for the use of DEA in Extremadura": It will be attached to the General Directorate with competences in matters of training of the Ministry responsible for health, which will exercise the functions of person responsible for the processing of personal data. This registry will be structured in three sections:

• — Section I. Authorized provider entities of training activities in the use of DEA in the non-health field: Those provider entities authorized to provide training in the use of DEA will be registered.
• — Section II. Instructors in the use of DEA in the non-health field: Those who intend to provide training in the use of DEA in Extremadura will be registered.
• — Section III. Persons authorized to use DEA in the non-health field: Those authorized persons will be registered. It will contain the personal identification data, the issuance dates of the individual authorization certificates and their renewal dates.

2. The rights of cancellation, rectification and opposition may be exercised before the bodies responsible for the processing of personal data included in the records created in this article.

The bodies responsible for the treatment, under the superior direction of the head of the Ministry competent in health, will adopt the management and organization measures that are necessary, ensuring, in any case, the use of the data contained therein for the purpose provided, as well as those leading to make effective the confidentiality, security and integrity of the data and other guarantees, obligations and rights recognized in the current regulations on the protection of personal data.

3. The modification of data referring to registered persons or entities may be carried out through:

• a) Declaration of responsibility in accordance with the provisions of annex II for the modifications of data collected in the DEA Extremadura Registry in the non-health field.
• b) Declaration of responsibility in accordance with the provisions of Annex VI when the modification refers to data in the Training Registry for DEA use in Extremadura.

 

CHAPTER V

Inspection, infractions and sanctions

 

Article 12

Inspection and control

 

1. The Health Directorates of each one of the Health Areas of the Autonomous Community of Extremadura, will carry out inspection and control actions of the installation requirements of the DEA and of the provider entities authorized for training, in order to ensure compliance according to with the provisions of this rule.
2. The inaccuracy, falsity or omission of an essential nature, in any data of the responsible declarations presented, after hearing the person concerned, entails nullifying the procedure and prevents continuing in the exercise of the activity from the moment in which there is evidence of this, without prejudice to the initiation of the pertinent actions and the requirement of the responsibilities provided for in current legislation. In the case of activities subject to a prior authorization regime, the subsequent verification of non-compliance with the necessary requirements for its granting may lead to the revocation of the authorization, prior to the initiation of the corresponding legal procedure.

 

Article 13

Infractions

 

Failure to comply with the obligations established in this decree will be considered administrative infractions, in accordance with the provisions of Law 10/2001, of June 28, on Health of Extremadura, and will give rise, prior instruction of the appropriate procedure, to the imposition of the corresponding administrative sanctions.

 

Article 14

Sanctions

 

1. Violations will be penalized with fines and other measures provided for in article 53 of Law 10/2001, of June 28, on Health of Extremadura.
2. The initiation, instruction and resolution of the disciplinary proceedings for the infractions included in this decree, will correspond to the bodies of the Ministry responsible for health and the Extremadura Health Service that are contemplated in this decree.

 

First additional provision

School of Health Sciences and Social Health Care

 

The status of authorized provider of training activities for the use of DEA is attributed to the School of Health Sciences and Socio-Health Care of Extremadura, as a public body that develops and executes training and improvement programs.

 

Second additional provision

access to information

 

For the purpose of obtaining information in relation to this regulation, citizens may access it through the electronic address of the Citizen Portal of the Junta de Extremadura: http://ciudadano.juntaex.es

 

Single transitional provision

Adaptation period

 

1. The holders of spaces that have an AED upon the entry into force of this decree, will have a period of six months to adapt to the fulfillment of the requirements demanded in it.
2. The holders of spaces obliged by this decree to install a DEA, but who do not have it when it comes into force, will have a period of twelve months to adapt to compliance with the requirements.

 

Unique derogatory provision

Regulatory repeal

 

Decree 10/2008, of January 25, which regulates the use of external semi-automatic defibrillators by non-medical personnel, and Order of October 23, 2009, which establishes the minimum accreditation requirements for Entities and training activities for the use of external semiautomatic defibrillators by non-medical personnel.

 

first final provision

Development and execution

 

The Minister of Health and Social Policies is empowered to issue the necessary provisions for the development and application of the provisions of this decree.

 

Second final provision

Entry into force

 

This decree will enter into force three months after its publication in the Official Gazette of Extremadura.

Merida, March 12, 2019.

 

The President of the Junta de Extremadura,

GUILLERMO FERNANDEZ VARA

 

The Minister of Health and Social Policies,

JOSE MARIA VERGELES BLANCA

 

Download here the regulations on DEA DESA defibrillators in Extremadura

 

We are defibrillator installers and cardiac rescue points

 

Neosalus Extremadura we carry out DEA defibrillator installations, we carry out equipment maintenance and training in SVB and use of the defibrillator with which to comply with the regulations on semi-automatic external defibrillators, comprehensive cardioprotection services in Extremadura. Contact us in Extremadura for any installation, maintenance or repair of DEA equipment that you may need, in facilities we certify cardioprotected spaces in Extremadura.